Early Stop(Ruling) of the Antibiotic Treatment During Pneumopathies d' Inhalation (APAPI)

Impact of a Strategy Based on the Unyvero® Testing System on Appropriate Antimicrobial Treatment in Patients With Suspected Aspiration Pneumonia Requiring Mechanical Ventilation : a Randomized Controlled Unblinded Trial

The two most common consequences resulting from aspiration are chemical pneumonitis and bacterial aspiration pneumonia. Both entities present with comparable clinical signs and symptoms. In the absence of a reliable clinical or biological marker to differentiate between these two conditions, most patients with suspected aspiration are treated empirically with antibiotics. De-escalation of initial antibiotic treatment is encouraged based on the results of microbiological results, usually performed before starting antimicrobial treatment. However, in most hospitals, 48-72h are required to obtain the results of microbiological cultures, and to de-escalate empirical large spectrum antibiotic treatment.

The use of the Unyvero®, a multiplex PCR-based testing system, for detection of respiratory bacterial pathogens would allow decreasing the percentage of patients with aspiration syndrome who will receive unappropriated antibiotic treatment at Day 3.

Study Overview

• Status: Completed
• Conditions: Aspiration Pneumonia
• Intervention / Treatment: Procedure: PCR-based microbiological diagnosis strategy; Procedure: Standard microbiological diagnosis strategy

• Study Type: Interventional
• Enrollment (Actual): 266
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Amiens, France
    • CHU Amiens Picardie
  • Lille, France
    • Hôpital Roger Salengro, CHU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• presence of risk factors for aspiration :
• known or likely swallowing dysfunction,
• altered consciousness,
• cardiac arrest,
• difficult intubation
• witnessed aspiration
• symptoms and signs suggestive of lower respiratory tract pathology
• temperature ≥38.5°C or <36°C
• leukocyte count ≥10 000/µL or <1500/µL
• purulent sputum or tracheal aspirate.
• new radiographic infiltrate on chest X-ray
• tracheal intubation and mechanical ventilation since less than 48 hours

Exclusion Criteria:

• pregnant women
• refuse to participate to the study
• no informed consent
• documented bacteremia
• septic shock
• severe immunosuppression: leukocytes<1000/L or neutrophils<500/L, chemotherapy during the last 3 months, organ transplant with chronic immunosuppressors use, HIV (CD4<50), and chronic corticosteroid use (>0.5 mg/kg day for at least one month during the last three months).
• moribund patients (SAPS II >90).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: multiplex PCR strategy; FilmArray® Pneumonia Panel plus	Procedure: PCR-based microbiological diagnosis strategy; A multiplex PCR-based testing, will be used in addition to standard microbiological culture of the tracheal aspirate to diagnose bacterial pneumonia after inhalation
Active Comparator: standard strategy	Procedure: Standard microbiological diagnosis strategy; Standard strategy will be based on with standard microbiological culture of the tracheal aspirate to diagnose bacterial pneumonia after inhalation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The percentage of patients who will benefit from an early stop of the probabilist antibiotic treatment	48 hours after antibiotic treatment initiation

Secondary Outcome Measures

Outcome Measure	Time Frame
the percentage of patients who will receive appropriate antibiotic treatment.	at Day 28 and Day 90 after antibiotic treatment initiation
the percentage of patients who will receive targeted antibiotic treatment.	at Day 28 and Day 90 after antibiotic treatment initiation
mechanical ventilation free days.	at Day 28 and Day 90 after antibiotic treatment initiation
length of ICU stay.	up to Day 90
ICU mortality.	up to Day 90
antibiotic free days.	up to Day 90
percentage of patients with colonization or infection related to multidrug-resistant bacteria (MDR)	at Day 28 and Day 90 after antibiotic treatment initiation

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Saadalla NSEIR, MD,PhD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2019
• Primary Completion (Actual): February 22, 2024
• Study Completion (Actual): February 22, 2024

Study Registration Dates

• First Submitted: December 3, 2018
• First Submitted That Met QC Criteria: December 3, 2018
• First Posted (Actual): December 4, 2018

Study Record Updates

• Last Update Posted (Estimated): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Antibiotics; PCR; Aspiration pneumonia; Invasive ventilation; Tracheal aspirate
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia; Pneumonia, Aspiration
• Other Study ID Numbers: 2018_40; 2018-A02219-46 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No